Louise Strom's practice focuses on UK and EU regulatory, and contentious matters affecting clients in the pharmaceutical, medical device, and food sectors. Ms. Strom advises on a broad range of issues that arise in the course of the product life cycle, including clinical research, authorisation, pricing and reimbursement, labeling, and promotional activity. She also assists life sciences companies in their development and implementation of global and regional compliance programmes.

Ms. Strom also maintains an active pro bono practice and regularly advises charities and NGOs on wide range of legal and strategic matters.

Before joining the firm, Ms. Strom trained and worked in the London and Brussels offices of a leading global law firm, where she focused her practice on dispute resolution. She has also worked in-house at a major financial institution and at a UK regulatory body.

Ms. Strom has a Master's degree in Medical Ethics and Law from King's College London, a Master's degree in Commercial Law from Cambridge University, and a first class honours Law LLB degree from Durham University. Ms. Strom is a native Swedish speaker.

Experience

  • Advising pharmaceutical companies with respect to promotional activities: advising on materials' compliance with UK/EU regulations and industry codes; preparing training materials on a range of promotional issues; participating in regular Medical-Legal Reviews; assessing product claims; coordinating multi-jurisdictional projects (e.g. regarding website requirements, off-label use, pricing and reimbursement); advising in relation to allegations of infringement of promotional rules.
  • Amicus Therapeutics, Inc. (Case T-33/17) in its European General Court case in relation to transparency of clinical trial data and access to documents held by the EMA.
  • Advising a generics manufacturer on a potential challenge of requirements under the Falsified Medicines Directive.
  • Evaluating pharmaceutical companies' internal procedures and commercial contracts for EU/UK regulatory compliance.
  • Preparing submissions to a UK public inquiry (product liability).
  • Advising a global consumer goods company on health and nutrition claims under EU and UK rules.
  • Advising on procedural elements of litigation.

Perspectives

Update on transparency of clinical data
BioSlice Blog
The Impact of Artificial Intelligence on Medical Innovation in Europe and United States
Digital Health Download
United Kingdom
Getting the Deal Through- Healthcare Enforcement & Litigation
The Impact of Artificial Intelligence on Medical Innovation in the European Union and United States (pdf)
Intellectual Property & Technology Law Journal, Vol. 29, No. 8
Disclosure of Clinical Trial Data by the EMA: Where are we now?
Clinical Trials Arena
More

Credentials

Education
  • MA, Medical Ethics and Law, King's College London, 2015, with distinction
  • Legal Practice Course, BPP Law School, 2010, with distinction
  • LLM, Cambridge University, 2008
  • LLB (Hons), Durham University, 2007, First Class
Admissions
  • England and Wales
Languages
  • Swedish
Overview

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